MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product performance engineering reviewed the reported information; however, the device was not returned for evaluation.A review of the electronic lot history record and similar incident query for this product was not performed since the lot number was not reported and the device was not returned for analysis.It should be noted that per electronic instructions for use (ifu), high torque command 18 guide wire for pta: this hi-torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (pta), in arteries such as the femoral, popliteal and infra-popliteal arteries.This guide wire may also be used with compatible stent devices during therapeutic procedures.The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.Although it was reported that the physician used the device in the wrong the anatomy, the reported violation of the ifu did not caused or contribute to the reported complaint.The investigation determined the reported difficulty to remove appear to be related to operational circumstances of the procedure.It is likely that during the procedure the delivery device or guide wire became damaged due to manipulation resulting in the difficulty to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to place a cardiomems sensor using a hitorque command 18 guide wire.The guide wire was inserted into the lower left lobe of the pulmonary artery.The sensor was deployed without incident, however; resistance was felt when removing the guide wire out of the delivery catheter.The delivery catheter and guide wire were removed as a single unit.There were no adverse patient effects and no clinically significant delay in the procedure.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10358257
• Report Number: 2024168-2020-06428
• Device Sequence Number: 2617648
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 122